EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE tablet, film coated

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

EMTRICITABINE (UNII: G70B4ETF4S) (EMTRICITABINE - UNII:G70B4ETF4S), TENOFOVIR DISOPROXIL FUMARATE (UNII: OTT9J7900I) (TENOFOVIR ANHYDROUS - UNII:W4HFE001U5)

Tilgjengelig fra:

NorthStar RxLLC

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Emtricitabine and tenofovir disoproxil fumarate tablets are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 17 kg [see Clinical Studies (14)].  Emtricitabine and tenofovir disoproxil fumarate tablets are indicated in at-risk adults and adolescents weighing at least 35 kg for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection. Individuals must have a negative HIV-1 test immediately prior to initiating emtricitabine and tenofovir disoproxil fumarate tablets for HIV-1 PrEP [see Dosage and Administration (2.2), Warnings and Precautions (5.2)]. Emtricitabine and tenofovir disoproxil fumarate tablets for HIV-1 PrEP is contraindicated in individuals with unknown or positive HIV-1 status [see Warnings and Precautions (5.2)]. Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to emtricitabine and tenofovir disoproxil

Produkt oppsummering:

Emtricitabine and tenofovir disoproxil fumarate tablets are available as follows: 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate (equivalent to 245 mg of tenofovir disoproxil) are white, capsule shaped, film-coated tablets debossed with "L-24" on one side and plain on the other surface. Bottle of 30 NDC 16714-534-01 Store below 30°C (86° F). • Keep container tightly closed • Dispense only in original container

Autorisasjon status:

Abbreviated New Drug Application

Informasjon til brukeren

EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE - EMTRICITABINE AND
TENOFOVIR
DISOPROXIL FUMARATE TABLET, FILM COATED
NorthStar RxLLC
----------
MEDICATION GUIDE
Emtricitabine and Tenofovir Disoproxil Fumarate Tablets
(EM-trye-SYE-ta-been and ten-OF-oh-vir DYE-soe-PROX-il FUEma-rate)
Read this Medication Guide before you start taking emtricitabine and
tenofovir disoproxil fumarate tablets
and each time you get a refill. There may be new information. This
information does not take the place of
talking to your healthcare provider about your medical condition or
your treatment.
This Medication Guide provides information about two different ways
that emtricitabine and tenofovir
disoproxil fumarate tablets may be used. See the section
“What is emtricitabine and tenofovir disoproxil fumarate tablets?”
for detailed information about how
emtricitabine and tenofovir disoproxil fumarate tablets may be used.
What is the most important information I should know about
emtricitabine and tenofovir disoproxil fumarate
tablets?
Emtricitabine and tenofovir disoproxil fumarate tablets can cause
serious side effects, including:
• Worsening of hepatitis B virus infection (HBV). Your healthcare
provider will test you for HBV before
start or when you start treatment with emtricitabine and tenofovir
disoproxil fumarate tablets. If you have
HBV infection and take emtricitabine and tenofovir disoproxil fumarate
tablets, your HBV may get worse
(flare-up) if you stop taking emtricitabine and tenofovir disoproxil
fumarate tablets. A “flare-up” is when
your HBV infection suddenly returns in a worse way than before.
•
Do not run out of emtricitabine and tenofovir disoproxil fumarate
tablets. Refill your prescription or
talk to your healthcare provider before your emtricitabine and
tenofovir disoproxil fumarate tablets
is all gone.
•
Do not stop taking emtricitabine and tenofovir disoproxil fumarate
tablets without first talking to
your healthcare provider.
•
If you stop taking emtricitabine and tenofovir disoproxil fumarate
tab

Preparatomtale

EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE - EMTRICITABINE AND
TENOFOVIR DISOPROXIL FUMARATE TABLET, FILM COATED
NORTHSTAR RXLLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
EMTRICITABINE AND
TENOFOVIR DISOPROXIL FUMARATE TABLETS SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING
INFORMATION FOR EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE
TABLETS.
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2004
WARNING: POSTTREATMENT ACUTE EXACERBATION OF HEPATITIS B AND RISK OF
DRUG
RESISTANCE WITH USE OF EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE
TABLETS FOR HIV-1 PRE-EXPOSURE PROPHYLAXIS (PREP) IN UNDIAGNOSED EARLY
HIV-1
INFECTION SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING.
• SEVERE ACUTE EXACERBATIONS OF HEPATITIS B (HBV) HAVE BEEN REPORTED
IN HBV-INFECTED
INDIVIDUALS WHO HAVE DISCONTINUED EMTRICITABINE AND TENOFOVIR
DISOPROXIL FUMARATE
TABLETS. HEPATIC FUNCTION SHOULD BE MONITORED CLOSELY IN THESE
INDIVIDUALS WHO
DISCONTINUE EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE TABLETS.
IF APPROPRIATE
ANTI-HEPATITIS B THERAPY MAY BE WARRANTED. (5.1)
• EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE TABLETS USED FOR
HIV-1 PREP MUST
ONLY BE PRESCRIBED TO INDIVIDUALS CONFIRMED TO BE HIV-NEGATIVE
IMMEDIATELY PRIOR TO
INITIATING AND AT LEAST EVERY 3 MONTHS DURING USE. DRUG-RESISTANT
HIV-1 VARIANTS HAVE
BEEN IDENTIFIED WITH THE USE OF EMTRICITABINE AND TENOFOVIR DISOPROXIL
FUMARATE TABLETS
FOR HIV-1 PREP FOLLOWING UNDETECTED ACUTE HIV-1 INFECTION. DO NOT
INITIATE EMTRICITABINE
AND TENOFOVIR DISOPROXIL FUMARATE TABLETS FOR HIV-1 PREP IF SIGNS OR
SYMPTOMS OF ACUTE
HIV INFECTION ARE PRESENT UNLESS NEGATIVE INFECTION STATUS IS
CONFIRMED. (5.2)
RECENT MAJOR CHANGES
Indications and Usage
HIV-1 Pre-Exposure Prophylaxis (PrEP) (1.2)
06/2020
Dosage and Administration
HIV-1 Screening for Individuals Receiving Emtricitabine and Tenofovir
Disoproxil Fumarate Tablets for HIV-1
(PrEP) (2.2) 06/2020
Warni